A dynamic simulation framework for biopharmaceutical capacity management.
Doctoral thesis, UCL (University College London).
In biopharmaceutical manufacturing there have been significant increases in drug complexity, risk of clinical failure, regulatory pressures and demand. Compounded with the rise in competition and pressures of maintaining high profit margins this means that manufacturers have to produce more efficient and lower capital intensive processes. More are opting to use simulation tools to perform such revisions and to experiment with various process alternatives, activities which would be time consuming and expensive to carry out within the real system. A review of existing models created for different biopharmaceutical activities using the Extend® (ImagineThat!, CA) platform led to the development of a standard framework to guide the design and construct of a more efficient model. The premise of the framework was that any ‘good’ model should meet five requirement specifications: 1) Intuitive to the user, 2) Short Run-Time, 3) Short Development Time, 4) Relevant and has Ease of Data Input/Output, and 5) Maximised Reusability and Sustainability. Three different case studies were used to test the framework, two biotechnology manufacturing and one fill/finish, with each adding a new layer of understanding and depth to the standard due to the challenges faced. These Included procedures and constraints related to complex resource allocation, multi-product scheduling and complex ‘lookahead’ logic for scheduling activities such as buffer makeup and difficulties surrounding data availability. Subsequently, in order to review the relevance of the models, various analyses were carried out including schedule optimisation, debottlenecking and Monte Carlo simulations, using various data representation tools to deterministically and stochastically answer the different questions within each case study scope. The work in this thesis demonstrated the benefits of using the developed standard as an aid to building decision-making tools for biopharmaceutical manufacturing capacity management, so as to increase the quality and efficiency of decision making to produce less capital intensive processes.
|Title:||A dynamic simulation framework for biopharmaceutical capacity management|
|Open access status:||An open access version is available from UCL Discovery|
|UCL classification:||UCL > School of BEAMS > Faculty of Engineering Science > Biochemical Engineering > Advanced Centre for Biochemical Engineering|
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